cGMP Certification: Current Good Manufacturing Practice
Independent third-party cGMP audits and certificates for dietary supplement, food, cosmetic, pharmaceutical and contract manufacturers, scoped to the US cGMP regulations that apply to your products.
- Audited against 21 CFR Part 111, Part 117 or Parts 210 and 211, as they apply to you
- On-site audit of your plant, people, processes and records
- Certificate buyers and brand owners can verify online
From $1,500Certified by EUROTECH
Or call +1 307 205 1833, Monday to Friday, 09:00 to 18:00 (US Mountain Time)
- Issuing certificates since 2004
- 500+ certificates issued
- On-site audits in the USA, Europe, Asia, Africa
- Verify any EUROTECH certificate
What is cGMP certification?
cGMP stands for current good manufacturing practice. It is the set of minimum requirements for the methods, facilities and controls used to make, package, label and hold products, so that every batch has the identity, strength, quality and purity it claims. In the USA, cGMP rules are part of the Code of Federal Regulations and are enforced by the Food and Drug Administration (FDA).
cGMP certification is an independent, third-party conformity assessment of those controls. A EUROTECH auditor visits your site and checks your practices and records against the cGMP regulation that applies to your products. After an independent review, we issue a certificate that names the site, the products, the activities and the reference audited. Buyers, brand owners, distributors and online marketplaces use it as evidence that your plant runs under documented, controlled conditions.
Certification sits alongside your legal duties, not in place of them. Manufacturers selling in the USA must comply with the applicable cGMP rules whether or not they hold a certificate, and only FDA inspects for regulatory compliance. A certificate shows how your site performed against the agreed reference on the audit date, and surveillance audits show that it stays that way.
GMP and cGMP: what is the difference?
The two terms describe the same idea. GMP is the general term used worldwide by WHO, the European Union, PIC/S and many national authorities. cGMP is the term used in US FDA regulations, where the small c stands for current.
The word current matters. FDA expects manufacturers to use technologies and systems that are up to date, not only those that were acceptable when the plant was built. Practices that were common ten years ago may fall short today, for example on data integrity, environmental monitoring or supplier qualification.
| Aspect | GMP | cGMP |
|---|---|---|
| Where the term is used | Worldwide: WHO, EU, PIC/S, national rules and ISO 22716 for cosmetics | US FDA regulations in Title 21 of the Code of Federal Regulations |
| Emphasis | Baseline controls for consistent, safe production | The same controls, applied with current technology and practice |
| Who usually asks for it | Distributors and authorities in many export markets | US importers, brand owners, retailers and online marketplaces |
| What our certificate states | The GMP reference audited | The 21 CFR part or parts audited |
If your customers ask for GMP against an international or food hygiene reference rather than US rules, our GMP certification may be the better fit. We help you choose at scoping.
Why cGMP matters for quality, safety and process control
Most product failures do not start in the formula. They start in the plant: a mix-up at weighing, a line that was not cleared, an untested raw material, a missed step in a batch record. cGMP controls are designed to stop those failures before a product leaves the site.
- Manufacturing quality: written specifications, master records and batch records make every batch repeatable and provable
- Product safety: hygiene, sanitation, pest control and identity testing reduce the risk of contamination and adulteration
- Process control: in-process checks, deviation handling and quality unit release keep decisions based on evidence
For a buyer, a current certificate is a fast, independent answer to a question they would otherwise need their own supplier audit to answer.
Benefits of cGMP certification
What an independent cGMP audit and certificate give your business, beyond a document on the wall.
Manufacturing quality assurance
Specifications, master manufacturing records and batch records are checked against the regulation, so each batch can be made the same way and proven afterwards.
Improved product safety
The audit looks closely at hygiene, sanitation, pest control, water and raw material testing: the controls that prevent contamination, mix-ups and adulteration.
Regulatory compliance support
An independent audit against 21 CFR shows gaps before a regulator or customer audit does. Every finding comes in a written report you can act on.
Customer and market confidence
Retailers, brand owners, importers and marketplaces often ask suppliers for third-party cGMP evidence. A certificate with a clear scope answers that request quickly.
Supply chain reliability
Brand owners can approve contract manufacturers and ingredient suppliers faster when they can check a current certificate on our verification portal.
Continuous improvement
Yearly surveillance audits, internal audits and corrective action tracking keep your system improving between audits, not only in the weeks before one.
Has a customer asked you for a cGMP certificate?
Tell us your products, sites and the markets you sell into. We confirm the applicable cGMP reference and send a written quote with audit days and every fee.
Industries we serve
cGMP requirements differ by product type. We scope each audit to the rules that apply to your products, and never mix the requirements of one sector with another.
Dietary supplements
21 CFR Part 111
Capsules, tablets, powders, gummies and liquids. The audit covers identity testing of each dietary ingredient, component and finished batch specifications, master manufacturing and batch production records, quality control release, complaints and returned products. Part 111 applies to firms that manufacture, package, label or hold supplements for the US market.
Food and beverage manufacturing
21 CFR Part 117
Bakeries, beverage fillers, snack, dairy and ingredient plants. Subpart B covers personnel hygiene, plant and grounds, sanitary operations and facilities, equipment, processes and controls, and warehousing. Facilities that register with FDA are generally also subject to hazard analysis and risk-based preventive controls, which we include where agreed.
Cosmetics and personal care
ISO 22716 and MoCRA
Creams, lotions, shampoos, colour cosmetics and fragrances. Cosmetics are not covered by Parts 111, 117 or 211. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) directs FDA to set GMP rules for cosmetic facilities, and ISO 22716 is the international cosmetics GMP standard most buyers ask for. We scope cosmetic audits to ISO 22716 and any FDA cosmetic GMP requirements in force at the time.
Pharmaceutical manufacturing
21 CFR Parts 210 and 211
Finished dosage forms such as tablets, capsules, liquids and semi-solids, including over-the-counter drugs. Part 211 covers the quality control unit, buildings, equipment, components and containers, production and process controls, packaging and labelling, laboratory controls and records. Our audit is a voluntary assessment for customers and partners, not a regulatory inspection.
Nutraceuticals
Part 111 or Part 117, by product
Nutraceutical is a market term, not a legal category. In the USA, a product sold as a dietary supplement falls under Part 111, while a functional food or drink falls under Part 117. We classify each product line with you at scoping, so the audit checks the rules that actually apply.
Contract manufacturing
Scope follows each product type
Contract manufacturers, private label producers and contract packers serve many brands at once. The audit covers each process area in scope, how client specifications and changes are agreed, and how quality agreements split responsibilities. FDA expects brand owners to stay responsible for products made for them, which is why they ask their manufacturers for cGMP evidence.
Packaging and related operations
Part 111, 21 CFR 174.5, Part 211
Packaging, labelling and holding operations, and makers of food contact or drug packaging. Packaging and labelling of supplements fall under Part 111. For food contact materials, 21 CFR 174.5 requires substances to be of suitable purity and used under good manufacturing practice. Drug containers and closures are controlled under Part 211 Subpart E. For food packaging hygiene, see EN 15593.
Applicable cGMP requirements
cGMP is not one regulation. FDA has written separate cGMP rules for different product types, and they are not interchangeable. The scope of your certification is set by the products you make and where you sell them, and the certificate names the reference audited.
21 CFR Part 111
Dietary supplements
Current good manufacturing practice in manufacturing, packaging, labeling or holding operations for dietary supplements.
- Personnel, physical plant and grounds
- Equipment and utensils
- Production and process control system
- Specifications and identity testing
- Master manufacturing and batch production records
- Holding, distribution, returns and complaints
21 CFR Part 117
Human food
Current good manufacturing practice, hazard analysis and risk-based preventive controls for human food, introduced under the FDA Food Safety Modernization Act.
- Subpart B: cGMP for hygiene, plant, sanitation, equipment and processes
- Warehousing and distribution
- Subpart C: hazard analysis and preventive controls
- Supply chain program and records
21 CFR Parts 210 and 211
Finished pharmaceuticals
Current good manufacturing practice for the manufacture, processing, packing or holding of finished drug products.
- Organization, personnel and the quality control unit
- Buildings, facilities and equipment
- Components, containers and closures
- Production, process, packaging and labeling controls
- Laboratory controls
- Records, reports, returned and salvaged products
Other GMP references
Other products and markets
Where US cGMP rules do not fit your product or market, we agree another recognised GMP reference with you.
- ISO 22716 for cosmetics
- 21 CFR 174.5 for food contact substances
- EU, PIC/S and WHO GMP guides for export markets
- 21 CFR Part 820 and ISO 13485 for medical devices, through our ISO 13485 service
We do not mix these rules. A plant making both supplements and conventional foods is audited against Part 111 for the supplement lines and Part 117 for the food lines, and the certificate scope shows both.
Our cGMP certification process
Eight clear stages from application to certificate. You know what happens next, who decides and what it costs before you commit.
- 1
Application and initial assessment
You send your products, sites, processes and employee numbers. We confirm we can audit your scope and send a written quote.
- 2
Scope and requirements review
We agree which cGMP reference applies to each product line, which sites and processes are in scope, and the audit plan and dates.
- 3
Documentation review
The auditor reviews your quality manual, SOPs, specifications and sample records before the visit, so time on site goes to practice, not paperwork.
- 4
cGMP audit
On site, the auditor follows materials from receipt to release, observes production and hygiene, interviews staff and traces batch records end to end.
- 5
Corrective actions, if required
Findings are explained in a written report. You send root cause, corrections and evidence within the agreed time, and we verify them.
- 6
Independent certification decision
A qualified reviewer who did not take part in the audit checks the audit file and makes the certification decision.
- 7
Certificate issuance
You receive a cGMP certificate naming the site, products, activities and reference audited, listed on our online verification portal.
- 8
Ongoing compliance and surveillance, where applicable
Yearly surveillance audits confirm that controls stay in place and review changes such as new products, lines, suppliers or sites.
Documentation requirements
Auditors judge cGMP on records. These are the documents we typically sample; the exact requirements depend on the regulation in scope.
Quality management documentation
Quality manual or policy, organisation chart, quality unit responsibilities, document control and management review.
Standard operating procedures (SOPs)
Approved, current procedures for receiving, production, cleaning, testing, release, complaints and recalls.
Manufacturing and process control records
Specifications, master manufacturing records, batch records, in-process checks, deviations and release decisions.
Personnel training records
Job descriptions, GMP and hygiene training, qualification for critical tasks and refresher training.
Cleaning and sanitation records
Cleaning schedules and logs, line clearance, pest control, water quality and environmental monitoring where applicable.
Equipment maintenance and calibration records
Equipment lists, preventive maintenance, calibration of scales and instruments, and equipment use logs.
Product traceability records
Lot coding, receipt and identity testing of components, distribution records and mock recall results.
Internal audit and corrective action records
Internal audit plan and reports, corrective and preventive action log, complaint investigations and trend reviews.
Retention periods differ by regulation. Part 111 records must be kept for one year past the shelf-life date, or two years after distribution of the last batch if no shelf-life date is used. Part 117 records must be kept for at least two years. Complete, current records keep the audit efficient.
Why choose EUROTECH for cGMP certification?
Professional certification services
EUROTECH has issued certificates since 2004, with more than 500 certificates issued to companies across several continents.
Experienced technical auditors
We assign auditors whose manufacturing background matches your product type, and confirm the audit team before the visit.
International client support
On-site audits in the USA, Europe, Asia and Africa, with our office in Sheridan, Wyoming and an agency office in Istanbul.
Transparent certification process
Audit days, travel and every fee are in a written quote before you commit. Findings and decisions come in writing.
Efficient application management
Combined audits with ISO 9001, ISO 22000 or ISO 22716 avoid checking the same records twice, and certificates can be checked online.
Industry-specific technical expertise
Our services cover supplements, food, cosmetics, packaging and medical devices, so a plant with several product types can be scoped under one plan.
Please note: EUROTECH cGMP certification is a voluntary third-party conformity assessment. FDA does not approve or certify facilities through third-party certificates. Our certificate does not replace FDA inspections, facility registration, drug approval or any other legal requirement in the markets where you sell.
Ready to start your cGMP certification?
Apply now or ask our certification team a question. We reply with the applicable reference, the audit plan and a written quote.
cGMP certification: frequently asked questions
What is cGMP certification?
It is an independent third-party audit of your manufacturing site against the US current good manufacturing practice regulation that applies to your products, followed by a certificate that states the scope and the reference audited.
How can I obtain a cGMP certificate?
Send us an application with your products, sites and employee numbers. We agree the scope, review your documents, audit your site, verify any corrective actions and, after an independent decision, issue the certificate.
What is the difference between GMP and cGMP?
Both describe the same controls. GMP is the general international term. cGMP is the term in US FDA regulations, where current means manufacturers must use up-to-date systems and technologies.
How long does cGMP certification take?
It depends on how ready your documentation is, the size of the site and whether corrective actions are needed. The on-site audit usually takes one to several days. We set out the timeline in your written quote.
How much does cGMP certification cost?
With EUROTECH it starts at $1,500. The final price depends on product types, production lines, employees, sites, the regulations in scope and travel, and is confirmed in a written quote.
Is cGMP certification required for dietary supplements?
Compliance with 21 CFR Part 111 is a legal requirement for firms that manufacture, package, label or hold dietary supplements for the US market. Third-party certification is voluntary, but many retailers, brand owners and marketplaces ask for it.
What is FDA 21 CFR Part 111?
It is the FDA regulation setting current good manufacturing practice for dietary supplements. It covers personnel, plant, equipment, specifications, identity testing of dietary ingredients, master and batch records, quality control, complaints and record keeping.
What is FDA 21 CFR Part 117?
It is the FDA regulation for human food. Subpart B sets cGMP requirements for hygiene, facilities, sanitation, equipment and processes, and later subparts set hazard analysis and risk-based preventive controls under the Food Safety Modernization Act.
Can food manufacturers obtain cGMP certification?
Yes. Food and beverage manufacturers are audited against the cGMP requirements of 21 CFR Part 117 and, where agreed, its preventive controls. Plants that also need a full food safety management system can combine it with ISO 22000.
What documents are required for cGMP certification?
Typically a quality manual, SOPs, specifications, master and batch records, and training, cleaning, calibration, traceability, internal audit and corrective action records.
Is a cGMP certificate the same as FDA approval?
No. FDA does not approve or certify facilities through third-party certificates. A cGMP certificate is a voluntary, independent assessment, and FDA inspections, registrations and product approvals remain separate.
Does FDA issue cGMP certificates?
No. FDA writes and enforces cGMP regulations and inspects facilities, but it does not issue cGMP certificates. When buyers ask for FDA cGMP certification, they usually mean a third-party certificate showing compliance with the FDA cGMP regulations, which is what we provide.
How long is a cGMP certificate valid?
Our cGMP certificates are valid for three years, with yearly surveillance audits to confirm that controls remain in place.
Related services
- GMP certification
From $1,500
- ISO 22716 cosmetics GMP
From $800
- ISO 22000 certification
From $800
- FDA registration
From $1,000
- ISO 9001 certification
From $800
- FSSC 22000
From $2,000
Request a quote for cGMP certification
Tell us your company, sites and the standard you need. We reply with a written quote and the audit plan.
Prefer to talk? Call +1 307 205 1833
Monday to Friday, 09:00 to 18:00 (US Mountain Time)